These devices are surgically implanted in persons who have a type of heart disease that creates the risk of a life-threatening heart arrhythmia (abnormal rhythm). The devices deliver an electrical shock to the heart to restore normal heart rhythm.

A deterioration in a wire insulator could cause a short circuit, resulting in the device’s inability to deliver an electrical shock during episodes of arrhythmia (abnormal heart rhythm) -- which could lead to a serious, life-threatening event for a patient.

Public Contact:

Consumers with questions may contact Guidant Corporation at 1-866-GUIDANT (1-866-484-3268)

FDA District:

Minneapolis

FDA Comment:

If you are not sure which model you have, or if you have other questions regarding your device, you should consult with your physician.

Continue to keep your normal doctor appointments.

If you feel a shock, contact your doctor as soon as possible.

If you or others hear "beeping" from your device, go immediately to your doctor or the emergency room.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

For additional information on this product recall, see the nearby links.